Octreotide versus hydrocortisone versus placebo in the prevention of post-ERCP pancreatitis: a multicenter randomized controlled trial
Octreotide versus hydrocortisone versus placebo in the prevention of post-ERCP pancreatitis: a multicenter randomized controlled trial
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DOI：
10.1067/mge.2002.122614
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发表时间：
2002-04-01
影响因子：
7.7
通讯作者：
Raptis, SA
中科院分区：
文献类型：
--
作者：
Manolakopoulos, S;Avgerinos, A;Raptis, SA
背景：奥曲肽是一种有效的胰腺分泌抑制剂，皮质类固醇抑制体液和细胞活性。两种药物均可降低ERCP术后胰腺炎的发生率。本研究的目的是确定奥曲肽和氢化可的松在预防ERCP后pancreatitis.Methods的有效性：354例患者进入一个多中心随机对照试验100 μ g皮下奥曲肽（组1）与100毫克静脉注射氢化可的松（组2）与生理盐水溶液作为安慰剂（组3）。所有药物均在手术前约30分钟给药。术前及术后3、12、24 h分别测定血清淀粉酶，并进行临床评估。第1组112例患者中有11例（9.8%）、第2组113例患者中有8例（7.1%）和第3组115例患者中有15例（13.0%）观察到胰腺炎（p = 0.32）。所有3组的平均住院天数相似：第1、2和3组的平均值（SD）分别为3.6（1.6）vs 2.9（0.6）vs 4.3（1.8）（p = 0.13）。多因素Logistic回归分析显示，胰腺注射，怀疑括约肌功能障碍，治疗程序，年龄的危险因素pancreatis.Conclusions：本试验的结果表明，奥曲肽和氢化可的松不能防止ERCP引起的胰腺炎。
Background: Octreotide is a potent inhibitor of pancreatic secretion, and corticosteroids suppress humoral and cellular activity. Both agents may reduce the frequency of post-ERCP pancreatitis. The aim of this study was to determine the effectiveness of octreotide and hydrocortisone in preventing post-ERCP pancreatitis.Methods: Three hundred fifty-four patients were entered in to a multicenter randomized controlled trial of 100 mug subcutaneous octreotide (Group 1) versus 100 mg intravenous hydrocortisone (Group 2) versus normal saline solution as placebo (Group 3). All medications were administered approximately 30 minutes before the procedure. Patients were assessed clinically and serum amylase was also measured before the procedure and 3,12, and 24 hours after the procedure.Results: Three hundred forty patients were included in the analysis. Pancreatitis was observed in 11 of 112 patients (9.8%) in Group 1, 8 of 113 (7.1%) patients in Group 2, and in 15 of 115 (13.0%) patients in Group 3 (p = 0.32). The mean length of hospitalization in days was similar in all 3 groups: mean (SD) for Groups 1, 2, and 3 were, respectively, 3.6 (1.6) versus 2.9 (0.6) versus 4.3 (1.8) (p = 0.13). Multivariate logistic regression analysis showed that number of pancreatic injections, suspicion of sphincter dysfunction, therapeutic procedure, and age were risk factors for pancreatitis.Conclusions: The results of this trial indicate that octreotide and hydrocortisone do not prevent ERCP-induced pancreatitis.